<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08908003989112</udiDi>
    <basicUdiDi>08908003989WallabyY5</basicUdiDi>
    <tradeName>Wallaby</tradeName>
    <deviceName>Infant Incubator with Accessories</deviceName>
    <manufacturerName>nice Neotech Medical Systems Pvt. Ltd.,</manufacturerName>
    <manufacturerSrn>IN-MF-000010243</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1208040301</emdnCode>
    <emdnDescription>FIXED NEONATAL INCUBATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>nice 3010</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:23:11.452Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260666386122</udiDi>
    <basicUdiDi>426066638incubatorsysH9</basicUdiDi>
    <tradeName>Transportinkubatorsystem</tradeName>
    <deviceName>Transportinkubatorsystem</deviceName>
    <manufacturerName>hestomed GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000007464</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1208040302</emdnCode>
    <emdnDescription>MOBILE NEONATAL INCUBATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04260666386122</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-27T22:09:20.211Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698887088802</udiDi>
    <basicUdiDi>B-08698887088802</basicUdiDi>
    <tradeName>Magic Loggia Ultimate M Neonatal Incubator</tradeName>
    <deviceName>Magic Loggia Ultimate M Neonatal Incubator</deviceName>
    <manufacturerName>ERTUNÇ ÖZCAN</manufacturerName>
    <manufacturerSrn>TR-MF-000016665</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1208040301</emdnCode>
    <emdnDescription>FIXED NEONATAL INCUBATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>126</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-23T23:49:40.316Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698887081933</udiDi>
    <basicUdiDi>B-08698887081933</basicUdiDi>
    <tradeName>Ertunç Özcan Magic Loggia M</tradeName>
    <deviceName>Magic Loggia M Neonatal Incubator</deviceName>
    <manufacturerName>ERTUNÇ ÖZCAN</manufacturerName>
    <manufacturerSrn>TR-MF-000016665</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1208040301</emdnCode>
    <emdnDescription>FIXED NEONATAL INCUBATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>110</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-23T23:49:37.914Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698887081926</udiDi>
    <basicUdiDi>B-08698887081926</basicUdiDi>
    <tradeName>Ertunç Özcan Magic Loggia Ultimate Neonatal Incubator</tradeName>
    <deviceName>Magic Loggia Ultimate Neonatal Incubator</deviceName>
    <manufacturerName>ERTUNÇ ÖZCAN</manufacturerName>
    <manufacturerSrn>TR-MF-000016665</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1208040301</emdnCode>
    <emdnDescription>FIXED NEONATAL INCUBATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>120</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-23T23:49:37.108Z</lastUpdated>
  </row>
  <row>
    <udiDi>59043588959274</udiDi>
    <basicUdiDi>B-59043588959274</basicUdiDi>
    <tradeName>Inkubator otwarty SRN-10M/SFT</tradeName>
    <deviceName>Stanowisko do resuscytacji noworodków SRN-10M/SFT</deviceName>
    <manufacturerName>ZAKŁAD URZĄDZEŃ MEDYCZNYCH UNIMED INŻ. ADAM ANDRUSZCZAK</manufacturerName>
    <manufacturerSrn>PL-MF-000008657</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1208040302</emdnCode>
    <emdnDescription>MOBILE NEONATAL INCUBATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SRN-10M/SFT</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:00:42.969Z</lastUpdated>
  </row>
  <row>
    <udiDi>59043588959267</udiDi>
    <basicUdiDi>B-59043588959267</basicUdiDi>
    <tradeName>inkubator otwarty SRN-10/SFT</tradeName>
    <deviceName>Stanowisko do resuscytacji noworodków SRN-10/SFT</deviceName>
    <manufacturerName>ZAKŁAD URZĄDZEŃ MEDYCZNYCH UNIMED INŻ. ADAM ANDRUSZCZAK</manufacturerName>
    <manufacturerSrn>PL-MF-000008657</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1208040302</emdnCode>
    <emdnDescription>MOBILE NEONATAL INCUBATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SRN-10/SFT</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:00:41.900Z</lastUpdated>
  </row>
  <row>
    <udiDi>59043588959182</udiDi>
    <basicUdiDi>B-59043588959182</basicUdiDi>
    <tradeName>Inkubator noworodkowy SRN-10M</tradeName>
    <deviceName>STANOWISKO DO RESUSCYTACJI NOWORODKÓW SRN-10M</deviceName>
    <manufacturerName>ZAKŁAD URZĄDZEŃ MEDYCZNYCH UNIMED INŻ. ADAM ANDRUSZCZAK</manufacturerName>
    <manufacturerSrn>PL-MF-000008657</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1208040302</emdnCode>
    <emdnDescription>MOBILE NEONATAL INCUBATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SRN-10M</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:00:37.995Z</lastUpdated>
  </row>
  <row>
    <udiDi>59043588959175</udiDi>
    <basicUdiDi>B-59043588959175</basicUdiDi>
    <tradeName>Inkubator otwarty SRN-10</tradeName>
    <deviceName>STANOWISKO DO RESUSCYTACJI NOWORODKÓW SRN-10</deviceName>
    <manufacturerName>ZAKŁAD URZĄDZEŃ MEDYCZNYCH UNIMED INŻ. ADAM ANDRUSZCZAK</manufacturerName>
    <manufacturerSrn>PL-MF-000008657</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1208040302</emdnCode>
    <emdnDescription>MOBILE NEONATAL INCUBATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SRN-10</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:00:37.056Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429063479</udiDi>
    <basicUdiDi>69454290NI003MU</basicUdiDi>
    <tradeName>Neonatal Incubator</tradeName>
    <deviceName>Neonatal Incubator</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1208040302</emdnCode>
    <emdnDescription>MOBILE NEONATAL INCUBATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B8A</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:41:36.261Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429063424</udiDi>
    <basicUdiDi>69454290BI001HL</basicUdiDi>
    <tradeName>Infant Incubator</tradeName>
    <deviceName>Infant Incubator</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1208040302</emdnCode>
    <emdnDescription>MOBILE NEONATAL INCUBATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B10</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:41:32.255Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429025163</udiDi>
    <basicUdiDi>69454290NI002MS</basicUdiDi>
    <tradeName>Neonatal Incubator</tradeName>
    <deviceName>Neonatal Incubator</deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1208040302</emdnCode>
    <emdnDescription>MOBILE NEONATAL INCUBATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B2</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:41:31.467Z</lastUpdated>
  </row>
  <row>
    <udiDi>04048675641308</udiDi>
    <basicUdiDi>040486751306012VK19Z0009N</basicUdiDi>
    <tradeName>Babyleo TN500</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Drägerwerk AG &amp; Co. KGaA</manufacturerName>
    <manufacturerSrn>DE-MF-000005329</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1208040301</emdnCode>
    <emdnDescription>FIXED NEONATAL INCUBATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2M61100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:57:04.838Z</lastUpdated>
  </row>
  <row>
    <udiDi>04048675436607</udiDi>
    <basicUdiDi>040486751306011VK19Z0008X</basicUdiDi>
    <tradeName>Babyleo TN500</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Drägerwerk AG &amp; Co. KGaA</manufacturerName>
    <manufacturerSrn>DE-MF-000005329</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1208040301</emdnCode>
    <emdnDescription>FIXED NEONATAL INCUBATORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>2M60000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:55:34.737Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429063431</udiDi>
    <basicUdiDi>69454290BI001HL</basicUdiDi>
    <tradeName>Infant Incubator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1208040302</emdnCode>
    <emdnDescription>MOBILE NEONATAL INCUBATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B10A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:56:53.702Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429063448</udiDi>
    <basicUdiDi>69454290BI001HL</basicUdiDi>
    <tradeName>Infant Incubator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1208040302</emdnCode>
    <emdnDescription>MOBILE NEONATAL INCUBATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B10B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:56:46.702Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429063455</udiDi>
    <basicUdiDi>69454290BI001HL</basicUdiDi>
    <tradeName>Infant Incubator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1208040302</emdnCode>
    <emdnDescription>MOBILE NEONATAL INCUBATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B10C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:56:20.048Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429025170</udiDi>
    <basicUdiDi>69454290NI002MS</basicUdiDi>
    <tradeName>Neonatal Incubator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1208040302</emdnCode>
    <emdnDescription>MOBILE NEONATAL INCUBATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B2A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T03:45:34.186Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429025187</udiDi>
    <basicUdiDi>69454290NI002MS</basicUdiDi>
    <tradeName>Neonatal Incubator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z1208040302</emdnCode>
    <emdnDescription>MOBILE NEONATAL INCUBATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B2B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T03:45:33.701Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945429090000</udiDi>
    <basicUdiDi>69454290NI003MU</basicUdiDi>
    <tradeName>Neonatal Incubator</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Comen Medical Instruments Co.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000002236</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1208040302</emdnCode>
    <emdnDescription>MOBILE NEONATAL INCUBATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B6</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T03:45:23.403Z</lastUpdated>
  </row>
</eudamedExport>